FALCON


Device Classification Name

transducer, ultrasonic

510(k) Number K111416
Device Name FALCON
Applicant
VIASONIX LTD.
1 odell plaza
yonkers, 
NY 
10701

Applicant Contact william stern
Correspondent
VIASONIX LTD.
1 odell plaza
yonkers, 
NY 
10701

Correspodent Contact william stern
Regulation Number 870.2880
Classification Product Code
JOP  
Date Received 05/20/2011
Decision Date 07/15/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No